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en-usTechdirt. Stories about "bayer"https://ii.techdirt.com/s/t/i/td-88x31.gifhttps://www.techdirt.com/Fri, 8 May 2015 14:33:42 PDTCalifornia Supreme Court Shows How Pharma 'Pay For Delay' Can Violate Antitrust LawsMike Masnickhttps://www.techdirt.com/articles/20150507/18011530932/california-supreme-court-shows-how-pharma-pay-delay-can-violate-antitrust-laws.shtml
https://www.techdirt.com/articles/20150507/18011530932/california-supreme-court-shows-how-pharma-pay-delay-can-violate-antitrust-laws.shtml"pay for delay" in the pharma industry. This involved patent holders paying generic pharmaceutical makers some amount of money to not enter the market in order to keep their own monopoly even longer. There's a complex process behind all of this, which often involves the larger pharmaceutical company first suing a generic maker, and then "settling" by agreeing to pay a sum of money to the generic maker. But, part of the "settlement" is that the generic drugmaker stays out of the market for longer than they otherwise would have needed to do so. Not surprisingly, the rise of such pay for delay, or "reverse payment" deals, came as a result of the Hatch-Waxman Act from 1984, which was supposed to encourage generic drugs to enter the market. But, because Congress does a really crappy job understanding game theory, those behind the bill failed to realize they were actually setting up incentives for the reverse (we'll get to how and why in a moment).

Either way, there have been a number of anti-trust lawsuits filed over these practices and finally, in 2013, in a case against Actavis, the Supreme Court ruled that these kinds of deals may violate antitrust laws, and the FTC had every right to use antitrust law against drugmakers. Late last year, the FTC finally put those powers to use (meanwhile, over in Europe, regulators have been going after the same practice).

And yet, even with the Supreme Court weighing in, all is not yet settled. Here in California, there was a separate case, revolving around pharma giant Bayer and the making of its super popular drug Cipro. There were a few different issues raised in this case, focusing mainly on whether California's state antitrust law could also be used against these deals (rather than just federal antitrust law) and also what "test" had to be used to determine if these deals violated the law (and, as part of that, whether you could presume that any such pay for delay deal must violate antitrust law).

The ruling itself [pdf] is a bit dense, but says that, yes, California's antitrust law does apply, and Bayer's efforts may violate antitrust law. But, in the process, it does a pretty good job laying out just how ridiculous the Hatch-Waxman Act was in terms of the incentives it actually set up, compared to the stated purpose of the bill:

The Hatch-Waxman Act illustrates the law of unintended consequences. Congress wrote into the act a substantial incentive for generics to enter markets earlier by offering a 180-day exclusivity period to the first generic filer, and only that filer, to challenge a patent.... The theory was that a generic would be more likely to challenge dubious patents if offered the carrot of an enormously valuable six-month period in which only it and the brand could produce a drug.... Otherwise, ―free rider‖ problems might arise: every generic would have an incentive to hold back and let some other generic be the one to shoulder the risk and litigation costs associated with challenging a patent.

In other words, somewhat incredibly, Hatch and Waxman basically decided the best way to encourage more non-monopoly-covered drugs on the market was... to grant them more monopolies. Ugh. What is it with politicians falsely assuming that everyone needs a government granted monopoly to do anything?

And, as with most government-granted monopolies, things don't quite go according to plan:

This solution may well have encouraged more generics to file patent challenges, but not without creating a series of new problems. In other settings, a patentee might have little incentive to buy off a challenger in order to preserve its monopoly and continue reaping monopoly profits, for the simple reason that paying off the first challenger would simply encourage another challenger, and then another, and then another.... Two features of the Hatch-Waxman Act change this dynamic. First, the 180-day exclusivity period created a bottleneck; no one else could receive FDA approval until after its expiration.... Second, other generics tempted to challenge a patent in the wake of a settlement with the first-filing generic would have to wait out an automatic 30-month stay the brand could obtain just by opposing their requests for FDA approval....

This legal regime means that, regardless of the degree of likely validity of a patent, the brand and first-filing generic have an incentive to effectively establish a cartel through a reverse payment settlement....

In other words, since Hatch-Waxman gives one generic company its own monopoly, the incentives are for the patent holder to figure out a way to pay off that company to not actually make use of that monopoly, thus allowing the original pharma company to keep its monopoly even longer.

Hey, how about we don't deal with the problems of government granted monopolies by piling more government granted monopolies on top of them? Just a thought...

And, because of all of these issues, it also can be used to block challenge to the validity of a pharma patent:

Rather than expend litigation costs on either side, the brand and generic can reach a settlement that reflects the likely validity or invalidity of the patent (stronger patent, smaller settlement; weaker patent, bigger settlement), grants the generic a share of monopoly profits, and leaves the brand the sole manufacturer of the product.

It is likely for this reason that reverse payment settlements, practically unheard of before the Hatch-Waxman Act, have proliferated in the years since its enactment.... This is probably not what Congress intended.

You think?

Either way, that question on the validity of the patent comes into play in the analysis of how antitrust law applies. After all, patents are technically an exception to antitrust law, since they're a government sanctioned monopoly. But what about an invalid patent?

Courts thus must reconcile the two bodies of law, making ―an adjustment between the lawful restraint on trade of the patent monopoly and the illegal restraint prohibited broadly by‖ antitrust law....

At the extremes, this is easy. If a patent were known to be invalid, a private agreement nevertheless giving it effect would be plainly illegal.... Conversely, if a patent were known to be valid, an agreement foreclosing competition no more than the statutory monopoly would not restrain trade beyond what federal law permitted, and the rights patent law affords the patentee would supersede any state law prohibition. Difficulties emerge when we move from a hypothetical patent known to be determinately valid or invalid to the real world, where validity may be unclear. When assessing the antitrust implications of an agreement arising from a patent, the truth about the patent‘s validity cannot always be known. The issue is how antitrust and patent law should accommodate each other under these conditions of uncertainty.

The ruling notes the importance of being able to regularly test the validity of patents to make sure bad patents don't stay in place, robbing the public domain (as well as the public of such benefits). Thankfully, the court recognizes that giving a government granted monopoly has tremendous costs, so they shouldn't just be given out willy-nilly:

Patents carry with them a frequent cost—monopoly premiums the public must bear.... The willingness to pay that cost depends upon a quid pro quo: ― " 'the public interest in granting patent monopolies‘ exists only to the extent that 'the public is given a novel and useful invention‘ in 'consideration for its grant.‘ " ... Accordingly, patent policy does not support unquestioned protection of every inventor‘s rights, but instead favors ―eliminating unwarranted patent grants so the public will not 'continually be required to pay tribute to would-be monopolists without need or justification.' " ... Vigorous testing for validity is thus desirable in order to weed out patents that shield a monopoly without offering corresponding public benefits.

And, in the end, the California Supreme Court notes that while it need not follow the lead of the federal Supreme Court in determining if patent law pre-empted antitrust law, the reasoning makes sense. As for which "test" to apply to see whether there is antitrust here, the Court notes that rather than hard-and-fast rules and buckets, the distinctions may be a bit more fuzzy than some assume. So rather than choosing one of the three big "rules" -- "rule of reason," "per se" or "quick look" -- the Court notes that there's more of a "sliding scale." Instead, it looks at the overall situation to determine if these practices violated antitrust law. The overall analysis is long and detailed, but the court recognizes that what's going on here and how these efforts can certainly harm the public, creating an "anticompetitive effect." It lays out a basic process for determining whether or not these agreements are anticompetitive, but rejects the idea that all such pay to delay deals must be anticompetitive (which would have been a nicer standard). Either way, this ruling certainly will make life more difficult for pharmaceutical companies looking to do pay to delay deals, meaning that it's good for the public and their health.

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]]>antitrusthttps://www.techdirt.com/comment_rss.php?sid=20150507/18011530932Mon, 27 Jan 2014 07:30:00 PSTBayer's CEO: We Develop Drugs For Rich Westerners, Not Poor IndiansGlyn Moodyhttps://www.techdirt.com/articles/20140124/09481025978/big-pharma-ceo-we-develop-drugs-rich-westerners-not-poor.shtml
https://www.techdirt.com/articles/20140124/09481025978/big-pharma-ceo-we-develop-drugs-rich-westerners-not-poor.shtml
We've covered the continuing efforts of emergingeconomies to provide key medicines for their populations at affordable prices. To do that, they often invoke their right to use compulsory licensing to bring down costs. For understandable reasons, the big pharma companies aren't happy with that approach, but usually dress it up as a concern about the supposed threat to "innovation" that it represents -- their claim being high prices are needed to fund expensive research. But as Techdirt has noted, pharma's estimates of expenditure here tend to be hugely inflated, which rather undercuts that argument.

"We did not develop this medicine for Indians," Dekkers said Dec. 3. "We developed it for western patients who can afford it."

That's a refreshingly honest admission that rather than wanting to save lives around the world, what Bayer is interested in is maximizing its profits by selling expensive drugs to "western patients who can afford it," and that those who can't pay can just, well, drop dead -- which, of course, is precisely what many of them will do without Bayer's drugs.

Some might say that's a perfectly reasonable position -- after all, Bayer and the other pharmaceutical companies are for-profit concerns. But they weren't always so dismissive of humanitarian concerns. Here's what George Merck, who became president of his father's eponymous chemical manufacturing company in 1929, said on the subject, as quoted on the Today in Science History site:

We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear. The better we have remembered it, the larger they have been.

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]]>refreshingly-honesthttps://www.techdirt.com/comment_rss.php?sid=20140124/09481025978Mon, 15 Apr 2013 03:52:24 PDTHow Big Agribusiness Is Heading Off The Threat From Seed Generics -- And Failing To Keep The Patent BargainGlyn Moodyhttps://www.techdirt.com/articles/20130405/09003022593/how-big-agribusiness-is-heading-off-threat-generics-failing-to-keep-patent-bargain.shtml
https://www.techdirt.com/articles/20130405/09003022593/how-big-agribusiness-is-heading-off-threat-generics-failing-to-keep-patent-bargain.shtmlevergreening" to extend their control over drugs as the patents expire. But this is also an issue for the world of agribusiness: a number of key patents, particularly for traits of genetically-engineered (GE) organisms, will be entering the public domain soon, and leading companies like Bayer, BASF, Dow, DuPont, Monsanto and Syngenta are naturally coming up with their own "evergreening" methods.

Making its position quite clear, ETC calls the approach "philanthrogopoly" -- a "charity" cartel that is designed to assuage fears that they represent an anticompetitive oligopoly, while simultaneously ensuring that real control remains with the agribusiness companies even after key patents have expired:

The Gene Giants know their market dominance looks conspicuously like an anticompetitive oligopoly, so they’re launching a series of initiatives -- including the false promise of cheap, post-patent GE seeds -- to mollify antitrust regulators and soften opposition to transgenics while advancing their collective market control.

Here's the problem that "philanthrogopoly" claims to address:

The looming crisis, according to the Gene Giants, is that when patents on biotech traits expire, the breeders who want to use these generic traits must have biosafety approval from the government authorities where they plan to export the GE commodity or cultivate the GE seeds. If biosafety authorizations are not kept up-to-date -- even for tiny traces of expired traits -- entire barges of transgenic beans, containers of biotech cotton or maize risk being rejected in Rotterdam, Dalian, or Yokohama. For US and other farmers who depend on exports of GE commodity crops, the presence of unauthorized generic traits could be devastating, according to industry. For example, one quarter of all US soybeans are
exported to China, and 95% of those beans are genetically engineered. An estimated 93% of GE soybeans in the United States contain a Monsanto trait that goes off-patent in 2014.

The complexity, however, is not just the biosafety review process; it's also the fact that re-registration requires legal access to the proprietary safety testing data initially submitted by one of the Gene Giants to government regulators. (For the Gene Giants, safety data are considered "confidential business information" and a protected trade secret -- it's not something they're accustomed to sharing, especially with competitors.) Without access to the proprietary information, the cost of bringing generic biotech crops to market would be prohibitive.

So what do the top players here propose in order to address this issue? They have come up with what they call, rather dramatically, "the Accord", which includes an option for patent holders to continue to oversee biosafety approval for their GE seeds, either alone, or working with other companies. As ETC points out, this is likely to lead to even closer cooperation among the leading agribusiness giants, which already have extensive cross-licensing agreements with each other.

One thing that the Accord will not lead to is a flood of low-cost seeds produced by generics companies, as has already happened in the world of pharma, with huge knock-on benefits for the world's poor. For that to happen, the key safety testing data held by the agribusiness giants would need to be available. And despite the reasonableness of requiring companies to do that -- after all, if they want people to eat their products, they should be prepared to release the scientific evidence it is safe to do so -- that's not likely to happen unless they are forced to by governments.

Another factor making it extremely unlikely that we will see many seed generics is the dense web of patents that now envelope GE varieties, as ETC explains:

In the words of Randy Schlatter, DuPont Pioneer's senior manager of intellectual property: "What growers may not realize is that even though the trait patent expires, there are a host of other intellectual property patents on those varieties that are just as strong." In an interview with DTN/Progressive Farmer, Schlatter observed: "If there is a [first generation genetically engineered] soybean in the market today that is truly generic and not protected by a patent of some sort, I've not been able to find it." DuPont Pioneer, the world's second biggest seed company, has more than 225 patents covering its portfolio of soybean seeds -- not just on transgenic traits -- but on breeding technologies, germplasm and conventional ("native") traits. Even if a single transgenic trait goes off patent, the maize or soybean variety that contains the trait is likely the subject of a complex web of intellectual property. The two dozen patents on biotech seed traits that will expire over the next decade are dwarfed by the thousands of existing patents on traits, seeds and varieties

This is similar to some of the approaches to evergreening in the pharma industry -- adding extra, patented features to older technologies as the latter enter the public domain. The net result is the same for both drugs and crops: the patent "bargain" with society, that a time-limited, government-backed monopoly is granted in return for allowing anyone to use the invention freely at the end of the patent term, is not being kept fully. Once more, the public is shortchanged.

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]]>bad-taste-in-the-mouthhttps://www.techdirt.com/comment_rss.php?sid=20130405/09003022593Mon, 4 Feb 2013 05:40:46 PSTBayer Fights India's Compulsory Licensing Of Cancer Drug By Claiming It Spent $2.5 Billion Developing ItGlyn Moodyhttps://www.techdirt.com/articles/20130123/07494121762/bayer-fights-indias-compulsory-licensing-cancer-drug-claiming-it-spent-25-billion-developing-it.shtml
https://www.techdirt.com/articles/20130123/07494121762/bayer-fights-indias-compulsory-licensing-cancer-drug-claiming-it-spent-25-billion-developing-it.shtmlBack in March last year, the Indian government announced that it was granting its first compulsory license, for the anti-cancer drug marketed as Nexavar, whose $70,000 per year price-tag put it out of reach of practically everyone in India. Nexavar's manufacturer, the German pharmaceutical giant Bayer, naturally appealed against that decision, and the hearing before the India Intellectual Property Appeals Board (IPAB) has now begun. Jamie Love has provided a useful report on the proceedings; here's his summary of what's at stake:

The outcome of this trial, which focuses on the cancer drug Nexavar, is a matter of first impression for the IPAB, and is expected to set precedents on a wide range of issues, including the permissible grounds for granting compulsory licenses, the relationship between the India patent law and the TRIPS Agreement, and the setting of terms and conditions for the compulsory license, including the royalty rates.

Clearly, then, this is a crucially important battle for both sides, and Bayer has started throwing around some huge R&D numbers in an attempt to convince the IPAB that it should be allowed to retain its monopoly in India to recoup those costs:

Bayer presented a January 9, 2013 affidavit from Harold Dinter which made the claim that from 1999 to 2005 Bayer had spent "2 billion euros (approximately US$ 2.5 billion) in the identification and development of anti-cancer molecules leading to the successful approval of Nexavar in 2005." Dinter did not provide detailed support for the numbers, but said they were based upon Bayer's general R&D outlays for anti-cancer drugs, including but not limited to Nexavar, and that the estimate was supported by a new December 2012 study by Jorge Mestre-Ferrandiz, Jon Sussex and Adrian Towse, published by the Office of Health Economics (OHE). Despite its name, the OHE is not part of the government, but rather a largely industry funded private consulting firm. The study itself was paid for by AztraZeneca. Dinter and Bayer's lawyer also made extensive reference to the work of Joseph DiMasi, an academic who is also a drug company consultant.

In other words, it's the usual "don't worry about the details, just take our word for it" lack of transparency that characterizes the entire pharma industry. But this $2.5 billion is insanely high, even for an industry that regularly inflates the outlay on drug development by an order of magnitude. As well as the generic implausibility of such a high figure, Love cites a number of specific reasons why it's extremely unlikely. You can read the details in his post, but here's a key section:

Bayer's partner in the development of Nexavar is Onyx Pharmaceuticals. Onyx published annual estimates of its R&D spending on Nexavar.

…

Bayer paid for all research from 1994 to 1999 ($26.1 million), and this included research on several compounds in addition to the one now marketed as sorafenib/Nexavar. From 2000 onward, Bayer and Onyx split the R&D costs 50:50, and Onyx's share of the R&D costs were $134.8 million. The outlays on the entire R&D program that lead to the 2005 approval of Nexavar for Kidney cancer were $26.1 + (134.8 x 2) = $295.7 million. Of the $295.7 million, only a fraction was spent on the development of Nexavar for kidney cancer, and some of that benefited from a 50 percent tax credit under the US Orphan Drug Act.

To the put the entire $295.7 million into perspective, ignoring the tax credits, that represents a little more than one quarter of the current global sales for sorafenib/Nexavar, a product that will maintain its monopoly in most markets through 2020.

$295.7 [million] is also just 11.8 percent of the $2.5 billion estimate that Bayer wants the IPAB to accept as its R&D costs.

No wonder that Bayer was unwilling to explain how it arrived at that extraordinary figure. But it's hard to see how the pharma company expects to win this case citing numbers that are basically an insult to the intelligence of India's experts.

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]]>ORLY?https://www.techdirt.com/comment_rss.php?sid=20130123/07494121762Fri, 5 Oct 2012 03:24:32 PDTEmerging Countries Take Note: Big Pharma's Losing Patent Battles In IndiaGlyn Moodyhttps://www.techdirt.com/articles/20120928/09573920539/emerging-countries-take-note-big-pharmas-losing-patent-battles-india.shtml
https://www.techdirt.com/articles/20120928/09573920539/emerging-countries-take-note-big-pharmas-losing-patent-battles-india.shtmlTechdirt has been following the important story of the kidney and liver cancer drug marketed under the name Nexavar since March, when India granted a compulsory license for the first time since re-instating patents on pharmaceuticals. Naturally, the patent holder, Bayer, fought back, and appealed against that decision. Now we learn from Intellectual Property Watch that Bayer has lost:

Last Friday (14 September), the Chennai-based Intellectual Property Appellate Board (IPAB) which is responsible for hearing appeals on patent applications, rejected a petition by German pharma major Bayer AG, seeking a stay on an order of India’s Controller of Patents granting a compulsory licence (CL) to Indian generic drug maker Natco Pharma Limited, for a drug used to treat liver and kidney cancer.

It's quite possible that Bayer will try to appeal to a higher court, but what's noteworthy is that this is just one of several other important pharma cases in India at the moment. For example, the Delhi High Court held that Roche’s patent on the cancer drug Tarceva was valid, but that an Indian generics manufacturer had not infringed on it because it had only been selling a variant of the drug. Another high-profile case concerns the blood cancer drug Gleevec, sold as Glivec in India, whose manufacturer, Novartis, is fighting India's refusal to grant it a patent. Here's the background:

The legal dispute in the Glivec case centres around a provision of India’s 2005 patent law, called Section 3(d), which states that "the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant." The dispute brings to the fore a fundamental question: what is an "invention"? Or more precisely, how much innovation is required to obtain a patent in India?

Novartis insists that it is not fighting in order to get more money, but to vindicate its "honor". What this probably means is that it is trying to establish the principle that patents can be given for new forms of drugs, even if they provide no enhancement over earlier versions. If it loses the Gleevec/Glivec case, that could have serious repercussions for future patent applications by the company in India.

More generally, this current round of high-profile drug patent cases may well have major knock-on effects in other regions of the world. Western pharma companies are probably worried that their recent failures in India to gain certain patents or block local manufacturers of generics could be repeated elsewhere as emerging countries wake up to the flexibilities within the TRIPS agreement that India is currently exploiting. The Intellectual Property Watch article mentions three nations that are already considering this -- Botswana, South Africa and Swaziland.

In trying to limit compulsory licences and avoid efficacy tests on products, the Bayer and Novartis cases are seeking to undermine public health considerations aimed at improving access and therapeutic advantage. The TRIPS Agreement does not limit the grounds on which compulsory licences can be granted, and does not prevent patent applicants from having to demonstrate enhanced efficacy for their allegedly new and useful inventions. There are many problems facing access to and rational use of medicines in India but the provisions within the country's patent laws, if more extensively and properly applied, should help rather than hinder such access. India's laws and experiences could provide a useful example for low-income and middle-income countries worldwide.

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]]>this-could-get-interestinghttps://www.techdirt.com/comment_rss.php?sid=20120928/09573920539Wed, 11 Jul 2012 13:54:00 PDTIndia Moves Even More Of Its Healthcare Away From Western PharmaGlyn Moodyhttps://www.techdirt.com/articles/20120710/12063819648/india-moves-even-more-its-healthcare-away-western-pharma.shtml
https://www.techdirt.com/articles/20120710/12063819648/india-moves-even-more-its-healthcare-away-western-pharma.shtmlA few years back, Techdirt noted that India had 16,000 licensed drug manufacturers in the 1990s, and became a net exporter of pharmaceutical products. Things changed somewhat when India joined the WTO, which forced it to recognize pharmaceutical patents, but more recently it has started moving back towards generics, notably with the compulsory licensing of a kidney and liver cancer drug that was being sold by Bayer in the country for around $70,000 a year.

From city hospitals to tiny rural clinics, India's public doctors will soon be able to prescribe free generic drugs to all comers, vastly expanding access to medicine in a country where public spending on health was just $4.50 per person last year.

The plan was quietly adopted last year but not publicized. Initial funding has been allocated in recent weeks, officials said.

Under the plan, doctors will be limited to a generics-only drug list and face punishment for prescribing branded medicines, a major disadvantage for pharmaceutical giants in one of the world's fastest-growing drug markets.

That's clearly going to have an immense effect on a country where 40% of the population live on $1.25 or less, meaning that paying for drugs is out of the question. The article quoted above estimates that 600 million people could take advantage of the scheme over the next five years.

But it will also have a major impact on the Western pharma companies, since it will effectively lock their products out of one of the two most important markets for the future. Combined with the compulsory licensing of more modern drugs, the latest move by India is deeply troubling for the world's main drug companies. That's reflected in both Bayer's attempt to contest the compulsory licensing order, and USPTO deputy director Teresa Stanek Rea's extraordinary claim that the move was in violation of TRIPS, clearly not the case.

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]]>why-pay-more?https://www.techdirt.com/comment_rss.php?sid=20120710/12063819648Tue, 3 Jul 2012 07:29:00 PDTThe USPTO: Where Up Is Down, Expensive Medicine Saves Lives, And Cheap Alternatives Violate International LawMike Masnickhttps://www.techdirt.com/articles/20120702/12502619555/uspto-where-up-is-down-expensive-medicine-saves-lives-cheap-alternatives-violate-international-law.shtml
https://www.techdirt.com/articles/20120702/12502619555/uspto-where-up-is-down-expensive-medicine-saves-lives-cheap-alternatives-violate-international-law.shtmldid this with a cancer drug made by Bayer called Nexavar. Despite the fact that Bayer has more than made back the money it spent bringing Nexavar to market, it's been pricing the drug at an unaffordable $70,000/year. After India allowed a small bit of competition, the price has dropped. We've seen that the USPTO doesn't like this at all and has tried to claim that high priced drugs are good for one's health, but that's beyond ridiculous to anyone who actually thinks.

Rea told the committee, saying she believes the issuance of the Indian compulsory license was in violation of the Agreement on Trade Related Aspects of Intellectual Property Rights, an international pact administered by the World Trade Organization which sets minimum standards for intellectual property regulation. Rea said the USPTO is working to stem the tide of IP infringement in foreign countries by the use of a host of training programs and educational efforts aimed at foreign officials and judges along with the placement USPTO overseas IP attaches in Thailand, China, Russia, India, Brazil and Egypt.

Article 31 of the TRIPS Agreement expressly permits compulsory licenses as does the much earlier Paris Convention on the Protection of Industrial Property. The U.S. Itself routinely makes government use of patented inventions pursuant to Congressional authority under 28 U.S.C. Sec. 1498, but also has other laws allowing compulsory licenses in specific circumstances. Compulsory licenses have been allowed globally in the vast majority of intellectual property regimes since the 19th century. And, the patent on Nexavar in India had been granted under a 2005 Amended Patents Act that clearly articulated compulsory licensing rights at the time that Bayer prosecuted its patent and the patent was granted.

Finally, and most to the point, the US signed the Doha Declaration on the TRIPS Agreement and Public Health that pointedly grants countries the right to issue compulsory licenses, to define the terms upon which such licenses are granted – without restrictions, and to define the emergency circumstances that permit licenses to be granted without any prior notice to or negotiation with the patent holder (note: these expedited, no-negotiation procedures were not used in the Natco case). Under the Doha Declaration, countries are permitted to issue compulsory licenses in order to ensure “access to medicines for all” – something that India has attempted to do via the license granted.

It's a shame that the USPTO appears to be so in the tank for big pharma (they get lots of patents, which helps pay USPTO salaries...), that they're willing to mislead Congress on issues like this, even if it means that very sick people around the globe don't get the medicines they need.

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]]>not-a-surprisehttps://www.techdirt.com/comment_rss.php?sid=20120702/12502619555Fri, 25 May 2012 10:21:00 PDTUS Gov't Tells Developing Nations That Patents & High Prices Are Good For The Health Of Their CitizensMike Masnickhttps://www.techdirt.com/articles/20120523/17340919053/us-govt-tells-developing-nations-that-patents-high-prices-are-good-health-their-citizens.shtml
https://www.techdirt.com/articles/20120523/17340919053/us-govt-tells-developing-nations-that-patents-high-prices-are-good-health-their-citizens.shtmlreducing the price of key drugs in India. And, no, this did not mean that the original manufacturer was unable to profit. This was on a drug where the company (Bayer) had made many times over its investment around the globe already, yet was still pricing the drug at over $5,000, while the generics were coming in at between $100 and $200.

There have been so many studies on this that you'd have to be either ignorant or deceitful to suggest that such a plan was a problem.

So I'm trying to figure out which adjective should apply to the USPTO, who recently gave a talk to a WIPO committee on the issue of patents and health, in which they argued that such efforts actually did more harm than good, and the way to keep people safe in developing countries was to increase patent protection:

There is no easy solution to these problems. Reducing patent protection is not likely to solve these thorny issues.... To the contrary, the lack of effective patent protection can be one of the many factors which prevent the appropriate medicines from reaching the neediest patients in DC and LDCs. Weakening the patent rights granted to pharmaceutical researchers and manufacturers in certain markets not only removes or reduces the incentive to develop new medicines, but also reduces the incentives for innovative medicine developers to invest in those countries and harness their innovation to solving the public health challenges that disproportionately affect developing countries, and are not being solved in other ways.

This statement is hogwash. First of all, there's nothing stopping these companies from profiting greatly in the developed world with these drugs, as they do already. And the idea that they wouldn't, say, invest in India if they could only get $100 per drug rather than $5,000... well, who cares? Considering how much more of these drugs they'd sell at those lower prices, there would still be plenty of profit to go around. Apparently, the folks at the USPTO have never learned a thing about price elasticity. Second, if a big pharma is too stupid to know how to provide drugs (which are relatively cheap to manufacture) at a reasonable cost for a profit, it seems pretty freaking natural that other companies are willing to step in and offer generics. So, really, why should anyone care if, say, Bayer decides to ignore India because it wants $5,000 for pills that others are willing to sell at $120? We're talking about the health and safety of the public, not Bayer.

Weakening patent protection for innovative medicines is not a productive approach to improving availability of health care, because many other factors other than patents more directly affect the availability of medicines.

The proof of the weakness of that argument is that although most medicines on the World Health Organization’s List of Essential Medicines are not protected by patents, their availability in many markets is still limited. This is particularly true in DC/LDCs. Many other factors affect the availability of all medicines, patented or not.

This is a nice bit of sleight of hand, confusing correlation with causation. No one says that a lack of patents means that such drugs are automatically made available in every market. But it takes a truly demented view of the world to take that fact and assume that such drugs would be more widely available if only those non-patented drugs were in fact covered by patent.

From there, the USPTO proposed a study to show how wonderful patents are in getting drugs to poor countries, to "restore balance to the discussion by evaluating the role of patent protection in providing incentives for research and development...." Funny how they were just talking about drugs that were off-patent not being available... but now they ignore that and it's all about new drug development. But, more seriously, I find it absolutely hilarious that the USPTO wants to talk about "restoring balance." This is an organization that has always pushed for "more patents" at pretty much any cost. The whole software industry is facing a massive crisis of gridlocked development over bogus patents. If we're going to start "restoring balance" to the patent system, let's start at home.

This kind of stuff is really sickening, because it's basically the USPTO saying that poor people around the globe should suffer and die if helping them doesn't produce enough profits for big pharmaceutical conglomerates. I don't know how people taking that position can sleep at night.

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]]>oh really now?https://www.techdirt.com/comment_rss.php?sid=20120523/17340919053Wed, 23 May 2012 20:01:00 PDTGenerics Drive Down Drug Prices In India, TPP Trying To Stop ThatGlyn Moodyhttps://www.techdirt.com/articles/20120523/03175119032/generics-drive-down-drug-prices-india-tpp-trying-to-stop-that.shtml
https://www.techdirt.com/articles/20120523/03175119032/generics-drive-down-drug-prices-india-tpp-trying-to-stop-that.shtmlBack in March, we wrote about an important development in India, where a compulsory license for Bayer's Nexavar anti-cancer drug was granted. Bayer, of course, is fighting back:

in its 37-page appeal to the Intellectual Property Appellate Board, Bayer has "demanded the withdrawal of the country’s first compulsory license given to Natco Pharma, arguing that a three-fourths reduction in the price of the anti-cancer drug by another Indian firm has made the permit redundant and its patent itself is vulnerable to being revoked," the Economic Times, India’s leading business newspaper, reported on 19 May. Bayer says CIPLA’s new price "will render Natco’s price unreasonable and defeat the purpose of compulsory licensing," according to the newspaper.

As that shows, there's been an interesting twist in this story. Cipla, another Indian manufacturer of generics, has announced that it too is coming out with a version of Nexavar, pricing it at $125 for 120 tablets. That's even cheaper than Natco's price of $163, to say nothing of Bayer's $5,128 for the same course. A key difference is that India's Patent Controller has granted a compulsory licence to Natco, but not to Cipla. In fact, Bayer has said that it is taking Cipla to court over its production of a cheap version of Nexavar.

Bayer is employing some very strange logic here. On the one hand, it is saying that Cipla's cheaper version of Nexavar means that Natco's licence is no longer needed, and should be revoked. On the other, Bayer is suing Cipla because it has produced Nexavar without the compulsory license that Natco has. Clearly, Bayer hopes to get the best of both worlds -- the revocation of Natco's compulsory licence, and a court ruling against Cipla, which would leave Bayer once more as the only supplier of Nexavar.

Bayer seems to be trying to make that outcome more palatable by emphasizing that it has already reduced the price of Nexavar for some people:

Bayer stresses that to facilitate access for patients to innovative treatments, it has had a Patient Access Programme in place since the launch of Nexavar in India in 2008. Bayer says that this programme, last expanded in April 2012, reduces the price for the monthly treatment with Nexavar for qualified persons to about a tenth of the regular pharmacy price (Rs 280,000 or $5,128) for the complete duration of treatment.

But it's not clear how many patients have actually benefited from this program. And in any case, the reduced price of $512 per 120 tablets is still three times higher than Natco's pricing, which would put it out of the reach of many poorer patients. Compulsory licensing, by contrast, has driven down the price to $163, and maybe even to $125 if Cipla is allowed to offer it too. In other words, the availability of indigenous alternatives has caused the price to drop from completely unaffordable levels to ones that are more realistic for the India market -- exactly as generics are supposed to do:

Health advocates and cancer patients are happy that the fight between the big brand-name pharmaceutical producers and local generic drug makers is making cancer drugs cheaper. The vast majority of Indians don’t have any form of health insurance and out of pocket payments continue to be among the highest in the world. Cancer has also become one of the ten leading causes of death in India today. It is estimated that there are nearly 2 – 2.5 million cancer cases at any given point in time in the country.

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]]>really-sickhttps://www.techdirt.com/comment_rss.php?sid=20120523/03175119032Mon, 12 Mar 2012 13:48:00 PDTPutting Lives Before Patents: India Says Pricey Patented Cancer Drug Can Be CopiedMike Masnickhttps://www.techdirt.com/articles/20120312/02424818071/putting-lives-before-patents-india-says-pricey-patented-cancer-drug-can-be-copied.shtml
https://www.techdirt.com/articles/20120312/02424818071/putting-lives-before-patents-india-says-pricey-patented-cancer-drug-can-be-copied.shtmldid away with drug patents entirely, believing it would help create a domestic drug industry. And it worked. As we discussed in the past:

2,237 licensed drug manufacturers in 1969-1970 grew to 16,000 by 1991-1993, production of drugs grew at an average rate of 14.4% per year from 1980 to 1993, India became a net exporter of pharmaceutical products, and the market share of foreign multinational corporations (MNCs) dropped from 80-90% to 40% (Fink 2005). In 1995, six of the top ten pharmaceutical firms in India were domestic, and employment in the sector had reached half a million people

Now, remember how people say that without intellectual property, industries protected by those monopolies collapse? Yeah, the opposite happened in India. And yes, many were producing generic versions, but not all of them were. Either way, despite all of this success, the international community, pressured by the big pharmaceutical firms, cracked down on such practices, and demanded that if anyone wanted to join the WTO -- an important organization for large countries to be a part of -- they had to recognize pharmaceutical patents as per the TRIPS agreement. India finally did so in 2005.

However, one key point in TRIPS that developing countries such as India and Brazil have paid close attention to is the fact that they can force a compulsory license on a drug patent holder in the interest of public health.

For the first time since re-instating patents on pharmaceuticals, India has granted just such a compulsory license, covering a kidney and liver cancer drug marketed under the name Nexavar. Indian generic drug company Natco requested a license, noting that Nexavar was in short supply in India and exceptionally expensive. A typical dosage costs around $70,000 per year in India -- something Bayer says is necessary to recoup the drug's R&D costs. However, reports show that it cost less than $300 million to develop this drug (not to mention that the US government subsidized the process) and Bayer has already made billions selling the drug around the world. In a detailed ruling (pdf and embedded below), India's Controller of Patents (nice title) granted Natco the right to make the same drug, requiring it to sell it at a significantly lower price than Bayer sells Nexavar for, and then pay back to Bayer a 6% royalty rate (which is actually at the high end of what the UN recommends). Natco has to make the drug itself and can't name it Nexavar, make it look the same or even state that it's the same as Nexavar -- but it can make its own version of the drug and sell it, and the license lasts the life of the patent. Bayer can and almost certainly will appeal, but this is going to be interesting to watch for a few reasons.

The real question here is how the US will react to this. The Obama administration has been trying to exempt drugs that treat non-communicable diseases (such as cancer medication!) from such compulsory license rights. In the meantime, the big (non-Indian) drug companies have been working hard to lock up the Indian drug market with patents. Not surprisingly, the Obama administration and the big drug companies have a cozy relationship when it comes to dealing with patents in India.

It's likely that you'll start to hear some rumblings from the US government about how this kind of ruling is a "problem" and how India isn't "respecting" international patent law. Expect to see diplomatic pressure placed on India to put limits on its compulsory licensing program, and potentially even noises about how India has to change its patent laws to "update" them and "harmonize" them with the world. Also don't be surprised if stuff like this leads India to jump up the charts on next year's Special 301 reports from the USTR, which list "naughty" countries. It's probably too late to make it into this year's list for this particular move. Is it really any wonder that India is so worried about ACTA? It knows that ACTA is entirely about ratcheting up enforcement, without any exceptions for things like this where something as important as saving lives comes into play.